Have you discovered a breach? Would you know what to do? What action should you take? Below are some steps you can take if you have discovered a breach in your practice.
Discovery of a Breach
A breach of PHI shall be treated as “discovered” as of the first day on which such breach is known to the organization, or, by exercising reasonable diligence would have been known to the organization (includes breaches by the organization’s business associates). The organization shall be deemed to have knowledge of a breach if such breach is known or by exercising reasonable diligence would have been known, to any person, other than the person committing the breach, who is a workforce member or agent (business associate) of the organization (see attachment for examples of breach of unsecured protected heath information). Following the discovery of a potential breach, the organization shall begin an investigation (see organizational policies for security incident response and/or risk management incident response), conduct a risk assessment, and based on the results of the risk assessment, begin the process to notify each individual whose PHI has been, or is reasonably believed to by the organization to have been, accessed, acquired, used, or disclosed as a result of the breach. The organization shall also begin the process of determining what external notifications are required or should be made (e.g., Secretary of Department of Health & Human Services (HHS), media outlets, law enforcement officials, etc.)
The organization shall name an individual to act as the investigator of the breach (e.g., privacy officer, security officer, risk manager, etc.). The investigator shall be responsible for the management of the breach investigation, completion of a risk assessment, and coordinating with others in the organization as appropriate (e.g., administration, security incident response team, human resources, risk management, public relations, legal counsel, etc.) The investigator shall be the key facilitator for all breach notification processes to the appropriate entities (e.g., HHS, media, law enforcement officials, etc.). All documentation related to the breach investigation, including the risk assessment, shall be retained for a minimum of six years. 45 CFR §164.530(j)(2)
For an acquisition, access, use or disclosure of PHI to constitute a breach, it must constitute a violation of the Privacy Rule. A use or disclosure of PHI that is incident to an otherwise permissible use or disclosure and occurs despite reasonable safeguards and proper minimum necessary procedures would not be a violation of the Privacy Rule and would not qualify as a potential breach. To determine if an impermissible use or disclosure of PHI constitutes a breach and requires further notification to individuals, media, or the HHS secretary under breach notification requirements, the organization will need to perform a risk assessment to determine if there is significant risk of harm to the individual as a result of the impermissible use or disclosure. The organization may choose to make the decision to notify patients of a breach even after completion of the risk assessment indicates that there is no requirement to do so under ARRA/HITECH. The organization shall document the risk assessment as part of the investigation in the incident report form noting the outcome of the risk assessment process. The organization has the burden of proof for demonstrating that all notifications were made as required or that the use or disclosure did not constitute a breach. Based on the outcome of the risk assessment, the organization will determine the need to move forward with breach notification. The risk assessment and the supporting documentation shall be fact specific and address:
- Consideration of who impermissibly used or to whom the information was impermissibly disclosed.
- The type and amount of PHI involved.
- The potential for significant risk of financial, reputational, or other harm.
Timeliness of Notification
Upon determination that breach notification is required, the notice shall be made without unreasonable delay and in no case later than 60 calendar days after the discovery of the breach by the organization involved or the business associate involved. It is the responsibility of the organization to demonstrate that all notifications were made as required, including evidence demonstrating the necessity of delay.
- Delay of Notification Authorized for Law Enforcement Purposes: If a law enforcement official states to the organization that a notification, notice, or posting would impede a criminal investigation or cause damage to national security, the organization shall:
- If the statement is in writing and specifies the time for which a delay is required, delay such notification, notice, or posting of the timer period specified by the official; or
- If the statement is made orally, document the statement, including the identify of the official making the statement, and delay the notification, notice, or posting temporarily and no longer than 30 days from the date of the oral statement, unless a written statement as described above is submitted during that time. 45 CFR § 164.412
Content of the Notice
The notice shall be written in plain language and must contain the following information:
- A brief description of what happened, including the date of the breach and the date of the discovery of the breach, if known.
- A description of the types of unsecured protected health information that were involved in the breach (such as whether full name, Social Security number, date of birth, home address, account number, diagnosis, disability code or other types of information were involved).
- Any steps the individual should take to protect themselves from potential harm resulting from the breach.
- A brief description of what the organization is doing to investigate the breach, to mitigate harm to individuals, and to protect against further breaches.
- Contact procedures for individuals to ask questions or learn additional information, which includes a toll-free telephone number, an e-mail address, Web site, or postal address.
Methods of Notification
The method of notification will depend on the individuals/ entities to be notified. The following methods must be utilized accordingly:
- Notice to Individual(s): Notice shall be provided promptly and in the following form:
- Written notification by first-class mail to the individual at the last known address of the individual or, if the individual agrees to electronic notice and such agreement has not been withdrawn, by electronic mail. The notification shall be provided in one or more mailings as information is available. If the organization knows that the individual is deceased and has the address of the next of kin or personal representative of the individual, written notification by first-class mail to the next of kin or person representative shall be carried out.
- Substitute Notice: In the case where there is insufficient or out-of-date contact information (including a phone number, email address, etc.) that precludes direct written or electronic notification, a substitute form of notice reasonably calculated to reach the individual shall be provided. A substitute notice need not be provided in the case in which there is insufficient or out-of-date contact information that precludes written notification to the next of kin or personal representative.
- In a case in which there is insufficient or out-of-date contact information for fewer than 10 individuals, then the substitute notice may be provided by an alternative form of written notice, telephone, or other means.
- In the case in which there is insufficient or out-of-date contact information for 10 or more individuals, then the substitute notice shall be in the form of either a conspicuous posting for a period of 90 days on the home page of the organization’s website, or a conspicuous notice in a major print or broadcast media in the organization’s geographic areas where the individuals affected by the breach likely reside. The notice shall include a toll-free number that remains active or at least 90 days where an individual can learn whether his or her PHI may be included in the breach.
- If the organization determines that notification requires urgency because of possible imminent misuse of unsecured PHI, notification may be provided by telephone or other means, as appropriate in addition to the methods noted above.
Notice to Secretary of Health and Human Services
Notice shall be provided to the Secretary of HHS as follows below. The Secretary shall make available to the public on the HHS Internet website a list identifying covered entities involved in all breaches in which the unsecured PHI of more than 500 patients is accessed, acquired, used, or disclosed. If the breach involves “secured” PHI, no notification needs to be made to HHS.
- For breaches involving 500 or more individuals, the organization shall notify the Secretary of HHS as instructed at hhs.gov at the same time notice is made to the individuals.
- For breaches involving less than 500 individuals, the organization will maintain a log of the breaches and annually submit the log to the Secretary off HHS during the year involved (logged breaches occurring during the preceding calendar year to be submitted no later than 60 days after the end of the calendar year). Instructions for submitting the log are provided at hhs.gov. For calendar year 2009, the organization is required to submit information to the HHS secretary for breaches occurring after the September 23, 2009 effective implementation date.
If you have discovered a breach in your practice, Tier3MD can help. Contact us at 855-698-4373